21 - Pharmacovigilance Flashcards
What’s the WHO definition of pharmacovigilance?
“The science and activities relating to detection, assessment, understanding and prevention of adverse events or any other drug-related problems”
Define
1) suspected ADR
2) Unexpected ADR
3) Serious vs non-serious ADR
4) SUSAR
1) ADR that might have a causal relationship
2) ADR that’s atypical based on drug characteristics
3) Serious = fata, life-threatening, disabling, or incapacitating
4) Serious unexpected suspected ADR
Define
1) Adverse effect
2) Signal
3) Which term is broader?
1) Harmful or unintended medical, clinical, or health outcome occuring during or following treatment. Doesn’t have to be related to drug use.
2) Info related to possible new ADR but needs further investigation.
3) Adverse effect. Signals are adverse effects with suspected ties to the drug use.
Define seriousness and severity. Difference?
Seriousness = Extent which ADR can cause harm
Severity = measure of intensity of ADR
Not interchangable terms. For example, an itch can be severe (very itchy) but a non-serious ADR (since not life threatening).
Difference between adverse effect and ADR?
Adverse effects can change something in a body without causing a symptom. For example, an adverse effect can cause raised aminotransferases but not cause any symptoms so not an ADR.
Pharmacovigilance involves… (8 total)
- Identify and quantify unrecognised ADRs
- Detect innapropriate prescriptions/administration of drugs
- Study effect of products mechanisms/properties and how it causes adverse effects
- Identify sub-groups prone to specific ADRs
- Evaluate harm-benefit
- Continued monitoring of product safety
- Respond to saftey concerns
- Confirm/refute signals
What’s proactive pharmacovigilance?
Pharmaceuticals submit Risk Management Plans (RMP) how they will obtain more knwoledge on drug saftey and perform risk-benefit analysis.
Who’s responsible for regulating NZ medicines and their safety?
- What do they do?
Medsafe
- Continually monitory risk/benefits of approved drugs
- Identify, assess, and take action on saftey issues that arise
CARM (Centre for Adverse Reaction Monitoring) is contracted by Medsafe to collect + analyse ADR reports
MARC (Medicines Averse Reactions Committee) provides expert advice on drug safety
What’s TPA in pharmacovigilance?
Proposed new legislation in 2022 to replace 1981 medicines act which now regulates NHPs as well.
1) Pharmacovigilance in NZ is run by…
2) Who can report to them?
1) CARM
2) Anyone
Essential elements of a suspected ADR report
- Patient details (name is optional)
- Reporter details (can be patient)
- Medicinal product details
- Adverse reaction details
What happens to an ADR report after it’s made?
- Assessed
- Seek further info if needed
- Databased analysed regularly to find patterns of ADRs and emerging saftey concerns
- MARC uses results to give recommendations to Medsafe
- Medsafe implements strategies for safer medicine use
What’s M2 in pharmacovigilance?
M2 Medicines Monitoring is when a signal is identified so increased monitoring happens. Health practitioners are asked to report any similar ADRs. Medsafe + CARM evaluate this info.
What’s the international monitoring program?
Uppsala Monitorying Centre (UMC). Collaborates w/ WHO. Collects data from full member countries.
Advantages and disadvantages of spontaneous reporting? (5 ad, 6 disad)
Advantages:
- Monitor all medicines all the time for every patient
- Early warnings
- Rare ADRs can be found
- Cheap
Disadvantages
- Under-identification + under-reporting
- Causal relationship can’t be guaranteed
- ADR frequency undetermined
- Quality of reporting can be low
- Herbal, traditional, and other NHPs hard to report.
